Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

AI industry, smart manufacturing, industrial automation-GettyImages-2297619541

Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?

With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.

GUEST COLUMNISTS

FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
Why You Should Measure Comparability Debt Before Ever Starting A Study
When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.
What FDA Inspectors Want From Your OOS File
Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.
You Can't CAPA What You Can't Classify
An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
AI Fills The Decision-Making Gaps In Process Analytical Technology
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.

PHARMA OUTSOURCING WHITE PAPERS

Drug Development Plan Explained: DPP Templates And Examples
Only 6.7% of Phase 1 drugs reach approval. A well-structured Drug Development Plan (DDP) can meaningfully improve your odds — learn exactly how to build one.

Controlling Complexity In ADC Formulation Development
ADC formulation development requires a molecule-specific approach that accounts for the interplay between antibody, linker, and payload, and the stability trade-offs that mAb development experience cannot fully anticipate.
Patented Process For Intermediates Useful For Deucravacitinib
Discover how this patented synthetic approach to Deucravacitinib intermediates can improve yield, simplify purification, and support scalable, regulatory-aligned manufacturing.
Modern Modeling Tools For Small Molecule Solid Dose Manufacturing
Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.
Better, Safer Science Through Proper Detergent Selection And Cleaning
Enforce reliable lab results by improving washer performance, detergent selection, and rinsing to prevent residues, cross-contamination, and spotting—supporting reproducibility and compliance.
Seasonal Vaccine Manufacturing: 3 Areas To Evaluate When Selecting A Partner
Experienced outsourcing partners will have the right facility and technical capabilities, a culture of speed and execution, and shared expectations and commitment to continuous improvement.